The Prescriber’s Role – Recognize and Report FDA’s educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading. The “Bad Ad” Program is administered by the agency’s Division of Drug Marketing, Advertising, and…
Newly Added Guidance Documents
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Drugs@FDA Data Files
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Proton Pump Inhibitors (PPIs) Video
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Drug Shortages Video
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Evamist Video
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Acetaminophen Information
Acetaminophen Safety Information January 13, 2011 FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure 1/13/2011 Questions and Answers about Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit 1/13/2011 FDA limits acetaminophen in prescription combination…
FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References  Safety Announcement [1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used…
Safe Use Initiative: FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention
 On October 22, 2010, the Food and Drug Administration held a workshop to discuss FDA regulated products implicated in surgical fires and challenges in eliminating fires. The workshop was organized by the Center for Drug Evaluation and Research’s Safe Use Initiative team and the Center for Devices and Radiological Health Division of Patient Safety…
FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary  Safety Announcement [12-22-2010] The U.S. Food and Drug Administration (FDA) is informing the public that results from a study conducted in France—the Santé Adulte GH Enfant (SAGhE) study—found that persons with certain kinds of short stature (idiopathic growth hormone deficiency and…